Cabometyx sNDA for Hepatocellular Carcinoma Indication Submitted to FDA
Exelixis has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Cabometyx (cabozantinib) as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC).
The submission is based on results from the CELESTIAL Phase 3 trial, a randomized, double-blind, placebo-controlled study involving patients with advanced HCC who received prior therapy with sorafenib (n=760). Patients were randomized 2:1 to receive cabozantinib 60mg once daily or placebo; the primary endpoint was overall survival with objective response rate and progression-free survival as secondary endpoints.
The results showed that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival compared with placebo (pre-specified critical P≤0.021).
Cabometyx, a kinase inhibitor, is currently approved for the treatment of patients with advanced renal cell carcinoma.
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